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510(k) K062126

EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 by Biosphere Medical, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2006
Date Received
July 26, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

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